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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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211 to 220 of 412 results
Decision Date To: 05/04/2024
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Download Files | More About De Novo
Device Name
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Requester
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De Novo
Number
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510(k)
Number
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Decision
Date
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LYRA DIRECT STREP ASSAY QUIDEL CORPORATION DEN140005 K133883 04/16/2014
LZI Carisoprodol Metabolite (Meprobamate Lin-Zhi International, Inc. DEN170010 04/20/2018
Magnetic Surgical System Levita Magnetics International Corp. DEN150007 06/13/2016
MALDI Biotyper CA System Bruker Daltonik GmbH DEN170081 04/20/2018
MAMMAPRINT AGENDIA BV DEN070009 K062694 02/06/2007
MANDOMETER III AB MANDO DEN070014 K063817 03/31/2011
Masimo SafetyNet Masimo Corporation DEN200011 03/31/2023
MATRx plus Zephyr Sleep Technologies DEN170090 08/23/2018
Medline ART Skin Harvesting System Medline Industries, Inc DEN210049 03/27/2024
Medtronic DUET External Drainage and Mon MEDTRONIC NEUROSURGERY DEN120017 08/22/2014
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